Acceptability and timing considerations when administering patient-reported outcome measures (PROMs) among people with chronic health conditions who are culturally and linguistically diverse (CALD): a qualitative study protocol

Abstract Introduction Patient-reported outcome measures (PROMs) are validated and standardised questionnaires that capture patients’ own reports of their symptoms, functioning and well-being. PROMs can facilitate communication between patients and clinicians, reduce symptom burden, enhance quality of life and inform health service re-design. We aim to determine the acceptability of PROMs and the preferred timing of PROM completion in New South Wales (NSW) at the point of care, facilitated by the Health Outcomes and Patient Experiences (HOPE) platform. Methods and analysis Semi-structured interviews with patients (~50-75, sampling across seven language groups and seven clinical cohorts), carers (~10–20) and clinicians (~18) enrolled in HOPE will be conducted via videoconference, telephone or in person. Participants will be asked questions about (1) what makes PROMs acceptable for use in chronic disease management (2) when patients would prefer to complete PROMs and when clinicians would like to use PROMs for clinical decision-making and (3) factors that impede the acceptability of PROMs for culturally and linguistically diverse patients. Interviews will be analysed using a reflexive thematic approach, guided by Normalisation Process Theory. Ethics and dissemination Ethics approval has been obtained from the Sydney Local Health District Human Research Ethics Committee (SLHD HREC, Study Protocol #X24-0138). Results will be published in appropriate peer-reviewed journals, presented at conferences, disseminated to participants in the form of a plain language summary, and widely disseminated to consumer groups and professional stakeholders.

1. Introduction, page 7, line 10: It is reported that HOPE is being implemented across all LHDs in NSW.It is later reported that PROMs will be routinely collected and used in HOPE (line 45).I am wondering if any of your prior implementation work was guided with a theory/model/framework-informed approach, using guidance from implementation science?Please briefly explain and provide an overview of how implementation of HOPE was operationalised.This could be useful for the readership interested in undertaking their own implementation work involving digital platforms.
2. Introduction, page 8: Please explain how you define acceptability, and which components of acceptability you are particularly interested in.
3. Methods, page 12, line 50: How was this sample size estimate derived? 4. Methods, page 15: It is mentioned that inductive coding will be undertaken, governed by NPT.I agree that NPT is particularly relevant for PROM implementation as it aims to understand how an innovation becomes routinised.However, please could you explain in a bit more detail how you will balance an inductive coding approach with the "fixed" key components of NPT? 5. Patient and public involvement: Please explain that you will follow GRIPP2 reporting guidelines to report PPI.

REVIEWER NAME Stern, Brocha REVIEWER AFFILIATION
Icahn School of Medicine at Mount Sinai

GENERAL COMMENTS
I appreciate the opportunity to review this interesting paper on a very timely and important topic.This is a protocol for a qualitative study of clinician and patient perspectives of acceptability and timing of patient-reported outcome measures collected in routine care for chronic conditions.I particularly value the inclusion of linguistically and culturally diverse patients.I have a few comments that may help with clarity of reporting.[Page numbers refer to the authors' page numbers.] • Abstract: P. 4, lines 20-201: Is this about determining the existing "timing" or preferences for/acceptability of timing?
• Abstract: P. 4, lines 30-31: Here, the sampling plan appears to be language x condition, which would mean many more participants than 75 if there are even just 5 per cell since there are 6 languages and 7 conditions.In contrast, p. 12, lines 50-54 just indicates purposeful sampling across the 6 languages.
• Abstract: P. 4, lines 35-41: Will patients be directly asked about cultural barriers?Or is this something the researchers will infer perhaps from comparing barriers between the English-speaking and CALD participants?More generally, these barriers aren't discussed elsewhere in the paper despite potentially being quite important and a more unique contribution of this study.
• General: The authors report that PROMs are collected across the care continuum, but the context could still be more clearly specified.Are these collected by physicians across the continuum?Multidisciplinary clinicians?Is there an anchor that starts off the continuum (e.g., a hospitalization related to one of these conditions)?• P. 8, "Theme 1: Acceptability"a) line 60: should it also refer to use by patients since the graphic talks about shared decision making?b) Inclusion of the non-completers is very valuable.But reasons for non-completion likely extend far beyond characteristics of the measure, which is the focus of acceptability in the graphic.
Will the conversation with these participants focus on measure characteristics?
• P. 10, Lines 36-41: Questions about timing will only be asked for participants in these two clinical groups?Also, "most informative" may be challenging to truly ascertain with just qualitative data.This seems to be about preferences and perspectives of optimal timing.• P. 11, lines 42-43: What does it mean to have assisted a patient with completion?Is this a caregiver/carer/partnerwill they also be eligible for enrollment?• P. 12, lines 42-43: How will the authors know before enrollment that the person can share their experiences in a thoughtful way?And this seems quite subjective.
• P. 12, lines 57-59: What does achieving data saturation "for each chronic condition and language" mean?Is this per unique cell?E.g., CHF Vietnamese?Can the authors even guarantee 1 patient per cell?They would need a larger sample for that.Or are the authors saying they will look across each condition regardless of language (e.g., CHF) and then separately look across language regardless of condition (e.g.

3.
Methods page 15, paragraph 3: "preferred timing of PROM completion".Abstract: P. 4, lines 30-31: Here, the sampling plan appears to be language x condition, which would mean many more participants than 75 if there are even just 5 per cell since there are 6 languages and 7 conditions.In contrast, p. 12, lines 50-54 just indicates purposeful sampling across the 6 languages.
Thank you for picking this up.We have now clarified recruitment targets on page 3 (Abstract) and 13, paragraph 1 (Methods): "We anticipate a patient participant sample size of ~50 across languages and chronic conditions (~5-10 per language group, non-specific targets across chronic conditions), ~10-20 carers, and a minimum clinician participant sample size of ~18, which will ensure coverage across the 18 LHDs in NSW.We will monitor recruitment closely and will update districts about the clinical areas that need a greater number of participants.Recruitment will continue until data thematic saturation is achieved for each chronic condition and language, which we define as being able to understand and explain the patient and clinician experience with no new explanations for choosing to complete or not complete PROMs[32]."Abstract: P. 4, lines 35-41: Will patients be directly asked about cultural barriers?Or is this something the researchers will infer perhaps from comparing barriers between the English-speaking and CALD participants?More generally, these barriers aren't discussed elsewhere in the paper despite potentially being quite important and a more unique contribution of this study.
We agree this is a unique and important contribution.Participants who identify as CALD will be asked specific questions related to cultural acceptability of PROMs and barriers to completion and use of PROMs.These differences may arise when comparing barriers between English-speaking and CALD participants.
We have included more detail on page 16, paragraph 1: "for patients who identify as CALD, if PROMs are culturally appropriate and suitable and if there are any specific barriers or enablers to PROM completion.For PROM non-completers, we will ask a different set of questions related to why patients and/or carers opted-out of PROM completion".General: The authors report that PROMs are collected across the care continuum, but the context could still be more clearly specified.Are these collected by physicians across the continuum?Multidisciplinary clinicians?Is there an anchor that starts off the continuum (e.g., a This is an important distinction you have raised.We have now clarified 'care continuum' as multidisciplinary healthcare teams, as well as when during a patient's care PROMs are collected (e.g., newly diagnosed with a chronic condition, at regular intervals during care, on deterioration of health status) on page 6, paragraph 1: We have added on page 11, paragraph 1: "semistructured interviews will allow patients to raise the concerns relevant to them, without constraint by the interviewer".P. 10, Lines 36-41: Questions about timing will only be asked for participants in these two clinical groups?Also, "most informative" may be challenging to truly ascertain with just qualitative data.This seems to be about preferences and perspectives of optimal timing.
Please note only participants recruited from COPD and/or heart failure clinical cohorts will be asked questions about timing of PROMs (as per our study aims).This is because of their distinct disease trajectories.
We agree that 'most informative' is challenging to address using qualitative research alone.However qualitative methods will facilitate a deeper understanding about the context of PROMs from an individual's perspective in the management of their chronic condition.We have amended to "informative" on page 10, aim 4.

P. 11, lines 42-43: What does it mean
to have assisted a patient with completion?Is this a caregiver/carer/partnerwill they also be eligible for enrollment?
We have clarified what assisted completion means on page 12: "have assisted a patient to complete PROM(s) (e.g., read questions and responses aloud) within HOPE as a carer/caregiver/family (i.e., not proxy completion)".
As caregiver/carer/partners are also eligible for recruitment to this study, we have added this into the eligibility criteria on: • Page 11, paragraph 3:"Patients and carers enrolled in the NSW Health PRMs program, who meet the following eligibility criteria, will be invited to this study" and Thank you for your review and enthusiasm for our proposed study.We appreciate your time and expertise during the revision of our manuscript.

• Specific research questions and aims on page 9 and 10: "What makes PROMs acceptable to carers who assist patients with chronic health conditions, including patients from CALD backgrounds?" and "To understand what makes PROMs acceptable to carers who are assisting patients with COPD, chronic heart failure, chronic kidney disease, diabetes and/or osteoarthritis to complete PROMs?" P. 12, lines 42-43: How will the authors know before enrollment that the person can share their experiences in a thoughtful way? And this seems quite subjective. We agree that this is subjective and hard to measure. have excluded this criterion from initial screening on page 12 as we cannot identify this feature within our proposed recruitment method of screening the HOPE database. P. 12, lines 57-59: What does achieving data saturation "for each chronic condition and language" mean? Is this per unique cell? E.g., CHF Vietnamese? Can the authors even guarantee 1 patient per cell? They would need a larger sample for that. Or are the authors saying they will look across each condition regardless of language (e.g., CHF) and then separately look across language regardless of condition (e.g., Vietnamese)? And how are clinicians factored into saturation? Thank you for picking this up. We have now clarified recruitment targets on page 3 (Abstract) and 13, paragraph 1 (Methods): "We anticipate a patient participant sample size of ~50 -75 across languages and chronic conditions (~5-10 per language group, non-specific targets across chronic conditions), ~10-20 carers, and a minimum clinician participant sample size of ~18, which will ensure coverage across the 18 LHDs in NSW. We will monitor recruitment closely and will update districts about the clinical areas that need a greater number of participants. Recruitment will continue until data thematic saturation is achieved for each chronic condition and language, which we define as being able to understand and explain the patient and clinician experience with no new explanations for choosing to complete or not complete PROMs[32]." P. 12, line 53: So the authors will purposely enroll 1 clinician per LHD? Will this be enough to ensure different professional/specialty voices? We aim to have a minimum of 1 clinician per LHD to represent each jurisdiction. However, depending on interest and availability, we may recruit more. We have added more detail on page 13, paragraph 1: "We will monitor recruitment closely and will update districts with regards to the clinical areas that need a greater number of participants." Role of the PROMIS-29 (p. 14, lines 37-40: Will this be sent to all patients even those who are not being assigned this measure? How will it be used during the interview? All patients, even if they have not completed PROMIS-29 (whether not assigned or opted-out by choice), will be provided with a copy of this PROM in their study information pack. This will be referred to at the start of the interview. If patients do not recall completing PROMIS-29, specific interview questions have been developed. We have clarified this further in the manuscript on page 15, paragraph 3: "At the start of the interview, the PROMIS-29 will be referred to by the interviewer to ascertain if the patient recalls completing this PROM. If the patient confirms they have not completed or opted out of completing this PROM, specific interview questions have been developed to understand why this is". P. 15, lines 10-22: These topics/questions don't directly align with previous topics mentioned, such as timing, etc. It would be helpful to the reader if the author more directly aligned the different sections, from the research questions, interview topics, data analysis, etc. On page 15, paragraph 3, we have now clarified interview topics to better align with our research questions and aims: "Participants who are recruited as patients or carers will be asked questions about: whether they believe the content of their assigned PROMs are appropriate to their lived experience with their condition; preferred timing for PROM completion; and for patients who identify as CALD, if PROMs are culturally appropriate and suitable, and if there are any specific barriers or enablers to PROM completion. For PROM non-completers, we will ask a different set of questions related to why patients and/or carers opted-out of PROM completion. Clinician participants will be asked to reflect on their use of PROMs during routine care and whether assigned PROMs are appropriate for their patients' disease trajectory and if the data is actionable in the context of chronic condition management and treatment."
Thank you to the authors for their thoughtful changes, which have clarified and strengthened the paper.I look forward to seeing the results of this important work.